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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| LanZhou University | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| The Second Affiliated Hospital of Baotou Medical College |
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This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone.
The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin.
The trial will be conducted at multiple centers, ensuring a broad and diverse patient population.
The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure.
This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal indometacin alone | Active Comparator | Participants in this arm will receive a rectal administration of 100mg indometacin 30 minutes prior to ESWL. This group will not undergo aggressive hydration and will instead receive restricted hydration measures. |
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| Aggressive hydration with rectal Indometacin | Experimental | Participants in this arm will also receive a rectal administration of 100mg indometacin 30 minutes before ESWL. In addition, they will undergo aggressive intravenous hydration using lactated Ringer's solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indometacin suppository | Drug | Administration of a 100mg indometacin suppository rectally 30 minutes prior to ESWL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-ESWL pancreatitis | Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of pancreatitis | Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment. | 1 month |
| Incidence of other post-ESWL complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang-Hao Hu | Contact | +8613817593520 | lianghao-hu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Baotou Medical College | Recruiting | Baotou | China |
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| OTHER |
| Shanghai Pudong New Area Gongli Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Affiliated Hospital of Yunnan University | OTHER |
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| Lactated ringers solution | Drug | Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h. |
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| Normal Saline | Drug | Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h) |
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Including bleeding, infection, steinstrasse, and perforation.
| 24 hours |
| Incidence of fluid overload | Including pulmonary or peripheral edema and congestive heart failure. | 24 hours |
| Transient adverse events related to ESWL | Transient adverse events were defined as transient injuries caused by shock waves that required no medical intervention and did not prolong hospitalisation, including asymptomatic hyperamylasaemia, haematuria, and acute gastrointestinal mucosal injury (eg, haematemesis, melena, or haem atochezia) caused by ESWL. Asymptomatic hyper amylasaemia was defined as an increase in serum amylase compared with pre ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. | 24 hours |
| Length of hospitalisation | 1 month |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| Hangzhou First People's Hospital | Recruiting | Hangzhou | China |
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| The Third Xiangya Hospital of Central South University | Recruiting | Hunan | China |
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| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | China |
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| Qilu Hospital of Shandong University | Recruiting | Shandong | China |
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| Changhai Hospital | Recruiting | Shanghai | China |
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| Ruijin Hospital | Recruiting | Shanghai | China |
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| Shanghai Pudong New Area Gongli Hospital | Recruiting | Shanghai | China |
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| Yunnan University Affiliated Hospital | Not yet recruiting | Yunnan | China |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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